2023-10-12 15:23:44
October 12, 2023
Carbamazepine is known to be a teratogenic drug, meaning it can cause serious malformations in children exposed during pregnancy. However, in 2022 in France, 274 pregnant women took it.
The National Medicines Safety Agency (ANSM) is launching the alert this Thursday, October 12. According to her, too many pregnancies still take place while the mother is still on carbamazepine. Prescribed in the treatment of epilepsy, mood disorders and certain pains, the drug is nevertheless known to be teratogenic, that is to say that it increases by three the risk of major malformations in children. to be born. “Malformations may include a neural tube defect (opening of the spinal column), a facial malformation, such as a cleft of the upper lip and palate, a skull malformation, heart anomalies, a malformation of the penis involving the urinary opening (hypospadias) and abnormalities in the fingers,” details the health agency.
The drug might also be associated with an increased risk of neurodevelopmental disorders in children exposed during pregnancy. A European evaluation is underway on this new data.
A tool for better patient information
However, according to figures reported to the ANSM, 274 pregnant women were receiving carbamazepine treatment in 2022. In order to correctly inform patients regarding the risks for the fetus, the ANSM announces that it is setting up a “certificate of shared information co-signed annually by the prescriber and the patient”. Dispensing of the medication in the pharmacy will be conditional on presentation of the document.
The ANSM also recommends that patients follow the following precautions:
- Use an effective method of contraception throughout the duration of treatment and two weeks following stopping. A subject that is important to discuss with your doctor because “carbamazepine may make your hormonal contraceptive, such as birth control pills, less effective”;
- If you plan to become pregnant, talk to your doctor in order to adapt the treatment;
- In the event of pregnancy, it is recommended to contact your doctor immediately without stopping treatment. “ Stopping suddenly can lead to an increase in seizures, which might have serious consequences for you and your child.. »
The agency also reminds health professionals that carbamazepine should not be used in women of childbearing age except as a last resort, to offer a pregnancy test before prescribing, and to regularly inform the patient of the risks concerning the carbamazepine. They are also informed that the use of the medication is no longer recommended in the treatment of neuropathic pain.
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Source : ANSM, October 12, 2023
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Written by : Dorothée Duchemin – edited by Vincent Roche
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